Advanced breast cancer with bone metastases
Conditions
Interventions
Product Name: Zometa
Product Code: Zometa
Pharmaceutical Form: Concentrate for solution for infusion
Sponsors
University of Sheffield
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Patients with advanced breast cancer (primary breast cancer having been histologically confirmed) with radiographic confirmation of bone metastases (at least one bone scan lesion must be confirmed as metastatic on plain radiographs or CT/MR imaging) •Patients who have received a minimum of 4 months of zoledronic acid to treat metastatic bone disease prior to first study treatment (i.e. a minimum of 4 or 5 zoledronic acid treatments prior to first study treatment for patients receiving 4- or 3-weekly infusions, respectively) •Men or women aged = 18 years •WHO (ECOG) performance status 0-2 •Women of child-bearing potential / men must be using a reliable and appropriate method of contraception. •Ability to read and complete the QoL questionnaires •Urine sample taken for central laboratory Ntx analysis prior to first study treatment •Written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Bisphosphonate treatment within the 3 weeks prior to planned first study treatment •More than 12 months bisphosphonate (any) treatment for metastatic bone disease prior to first study treatment •Less than 4 months zoledronic acid treatment specifically for metastatic bone disease prior to first study treatment •Abnormal renal function as evidenced by a calculated creatinine clearance 3 × upper limit of normal [ULN] or bilirubin > 1.5 × ULN - from blood taken within 28 days of randomisation) •Treatment with systemic bone seeking radioisotopes (e.g. strontium, samarium) within the 3 months prior to randomisation •Wide field (hemi-body) radiotherapy within the 3 months prior to randomisation - recent standard field, localised radiotherapy is not an exclusion criteria •Concomitant medication with drugs known to affect bone metabolism - calcitonin, high dose systemic corticosteroids (> 10 mg prednisolone/day or equivalent) •Pregnancy or breast-feeding •Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular), or a current or prior diagnosis of osteonecrosis of the jaw (ONJ) •Recent (within 4 weeks of randomisation) or planned dental or jaw surgery (e.g. extractions, implants) •History of prior cancers within the preceding 5 years (aside from ipsilateral / contralateral breast, non-melanomatous skin cancer, carcinoma in situ of the uterine cervix or superficial bladder cancer treated with curative intent)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of the study is to investigate whether patients with breast cancer that has spread to the bones need a zoledronic acid treatment every 3-4 weeks as per the "standard" clinical schedule (i.e. how often it is given) or whether the schedule of zoledronic acid could be tailored to the individual patient by measuring the level of bone breakdown through a urine test. The primary objective of the study will be to compare the frequency (number) and timing of all skeletal related events (SREs) between the two schedules. Skeletal related events (SREs) are defined as bone complications such as fractures, additional treatment to the bone (e.g. radiotherapy or surgery), spinal cord compression and hypercalcaemia of malignancy. ; Secondary Objective: The secondary objectives of the study are to compare the impact of both treatment regimens on: - Patient quality of life - The clinical burden of skeletal complications - Pain, performance status and analgesic use - The incidence of new bone metastases - Overall survival - Bisphosphonate use and expenditure on administration There are also three sub-studies that will compare the impact of both treatment regimens on the following in a sub-set of the trial patients: - Health care utilisation - Evaluation of the clinical use of a local "point of care" test as a means of calculating bone marker levels - Changes in serum markers of bone metabolism ; Primary end point(s): To compare the frequency and timing of all skeletal related events (SREs). SREs are defined as: - Fractures: All clinical fractures will be reported and classified by site and shether considered to be disease related (i.e. pathological) or traumatic. In addition all fractures identified on follow- | — |
Countries
United Kingdom
Outcome results
None listed